what if you run with a view that there will actually be 3 x trials?
- AU
- EU
- USA
And the totality of these rolling up into 1 complete Phase 2/3 trial...
Each jurisdiction has differing requirements / thresholds / tax laws / etc etc so maybe it is actually a combo approach.
It would explain why MT was confident of starting the trail in H1 in AU... ODD has no bearing if you run an AU trail that is designed to dovetail into an EU and USA trail to deliver local and international scientific requirements - but maybe not tax etc as that is a local issue.
My head has pivoted to this approach being more likely after chats with a few folks.
The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-1286
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